The impact of inter-laboratory glucose bias on the diagnosis of gestational diabetes mellitus: Comparison of common automated central laboratory methods

Cathrine Munk Scheuer; Casper Duevang Tvarnø; Charlotte Gils; Julie Dahl Ravn; H David McIntyre; Dorte Møller Jensen; Peter Damm; Jeannet Kepp Bruun Lauenborg; Tine Dalsgaard Clausen; Martin Overgaard

doi:10.1016/j.cca.2023.117414

The impact of inter-laboratory glucose bias on the diagnosis of gestational diabetes mellitus: Comparison of common automated central laboratory methods

Cathrine Munk Scheuer^*, Casper Duevang Tvarnø, Charlotte Gils, Julie Dahl Ravn, H David McIntyre, Dorte Møller Jensen, Peter Damm, Jeannet Kepp Bruun Lauenborg, Tine Dalsgaard Clausen, Martin Overgaard

^*Corresponding author for this work

Abstract

BACKGROUND AND AIMS: The diagnosis of gestational diabetes mellitus (GDM) is based exclusively on glucose measurements, which are highly influenced by pre-analytical and analytical factors. Therefore, poor agreement across laboratories may affect the prevalence of GDM. We aimed to determine the inter-laboratory bias of glucose measurements and the impact on GDM prevalence.

MATERIAL AND METHODS: A prospective cohort study of women (n=110) referred for second-trimester GDM diagnostics using a 75 g oral glucose tolerance test. Maternal glucose was assessed from venous plasma at fasting, 1 h and 2 h. Venous blood were collected in Fluoride Citrate tubes and frozen. Samples were analyzed at five central laboratories using four different automated glucose Hexokinase methods and GDM prevalence was evaluated according to WHO2013 diagnostic criteria.

RESULTS: Maximum inter-laboratory bias was 0.19, 0.30 and 0.27 mmol/L in fasting, 1 h and 2 h samples, respectively. GDM prevalence ranged 30.0-41.1% across laboratories.

CONCLUSION: Inter-laboratory bias for mean venous glucose was low and within desirable limits. Nonetheless, the impact on GDM prevalence was considerable, which may inappropriately affect clinical practice.

Original language	English
Article number	117414
Journal	Clinica chimica acta; international journal of clinical chemistry
Volume	546
ISSN	0009-8981
DOIs	https://doi.org/10.1016/j.cca.2023.117414
Publication status	Published - Jun 2023

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Munk Scheuer, C., Duevang Tvarnø, C., Gils, C., Dahl Ravn, J., David McIntyre, H., Møller Jensen, D., Damm, P., Kepp Bruun Lauenborg, J., Dalsgaard Clausen, T., & Overgaard, M. (2023). The impact of inter-laboratory glucose bias on the diagnosis of gestational diabetes mellitus: Comparison of common automated central laboratory methods. Clinica chimica acta; international journal of clinical chemistry, 546, Article 117414. https://doi.org/10.1016/j.cca.2023.117414

The impact of inter-laboratory glucose bias on the diagnosis of gestational diabetes mellitus: Comparison of common automated central laboratory methods. / Munk Scheuer, Cathrine; Duevang Tvarnø, Casper; Gils, Charlotte et al.
In: Clinica chimica acta; international journal of clinical chemistry, Vol. 546, 117414, 06.2023.

Research output: Contribution to journal › Journal article › Research › peer-review

Munk Scheuer, C, Duevang Tvarnø, C, Gils, C, Dahl Ravn, J, David McIntyre, H, Møller Jensen, D, Damm, P , Kepp Bruun Lauenborg, J , Dalsgaard Clausen, T & Overgaard, M 2023, 'The impact of inter-laboratory glucose bias on the diagnosis of gestational diabetes mellitus: Comparison of common automated central laboratory methods', Clinica chimica acta; international journal of clinical chemistry, vol. 546, 117414. https://doi.org/10.1016/j.cca.2023.117414

Munk Scheuer C, Duevang Tvarnø C, Gils C, Dahl Ravn J, David McIntyre H, Møller Jensen D et al. The impact of inter-laboratory glucose bias on the diagnosis of gestational diabetes mellitus: Comparison of common automated central laboratory methods. Clinica chimica acta; international journal of clinical chemistry. 2023 Jun;546:117414. Epub 2023 May 30. doi: 10.1016/j.cca.2023.117414

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title = "The impact of inter-laboratory glucose bias on the diagnosis of gestational diabetes mellitus: Comparison of common automated central laboratory methods",

abstract = "BACKGROUND AND AIMS: The diagnosis of gestational diabetes mellitus (GDM) is based exclusively on glucose measurements, which are highly influenced by pre-analytical and analytical factors. Therefore, poor agreement across laboratories may affect the prevalence of GDM. We aimed to determine the inter-laboratory bias of glucose measurements and the impact on GDM prevalence.MATERIAL AND METHODS: A prospective cohort study of women (n=110) referred for second-trimester GDM diagnostics using a 75 g oral glucose tolerance test. Maternal glucose was assessed from venous plasma at fasting, 1 h and 2 h. Venous blood were collected in Fluoride Citrate tubes and frozen. Samples were analyzed at five central laboratories using four different automated glucose Hexokinase methods and GDM prevalence was evaluated according to WHO2013 diagnostic criteria.RESULTS: Maximum inter-laboratory bias was 0.19, 0.30 and 0.27 mmol/L in fasting, 1 h and 2 h samples, respectively. GDM prevalence ranged 30.0-41.1% across laboratories.CONCLUSION: Inter-laboratory bias for mean venous glucose was low and within desirable limits. Nonetheless, the impact on GDM prevalence was considerable, which may inappropriately affect clinical practice.",

author = "{Munk Scheuer}, Cathrine and {Duevang Tvarn{\o}}, Casper and Charlotte Gils and {Dahl Ravn}, Julie and {David McIntyre}, H and {M{\o}ller Jensen}, Dorte and Peter Damm and {Kepp Bruun Lauenborg}, Jeannet and {Dalsgaard Clausen}, Tine and Martin Overgaard",

note = "Copyright {\textcopyright} 2023. Published by Elsevier B.V.",

year = "2023",

month = jun,

doi = "10.1016/j.cca.2023.117414",

language = "English",

volume = "546",

journal = "Clinica chimica acta; international journal of clinical chemistry",

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T1 - The impact of inter-laboratory glucose bias on the diagnosis of gestational diabetes mellitus

T2 - Comparison of common automated central laboratory methods

AU - Munk Scheuer, Cathrine

AU - Duevang Tvarnø, Casper

AU - Gils, Charlotte

AU - Dahl Ravn, Julie

AU - David McIntyre, H

AU - Møller Jensen, Dorte

AU - Damm, Peter

AU - Kepp Bruun Lauenborg, Jeannet

AU - Dalsgaard Clausen, Tine

AU - Overgaard, Martin

PY - 2023/6

Y1 - 2023/6

N2 - BACKGROUND AND AIMS: The diagnosis of gestational diabetes mellitus (GDM) is based exclusively on glucose measurements, which are highly influenced by pre-analytical and analytical factors. Therefore, poor agreement across laboratories may affect the prevalence of GDM. We aimed to determine the inter-laboratory bias of glucose measurements and the impact on GDM prevalence.MATERIAL AND METHODS: A prospective cohort study of women (n=110) referred for second-trimester GDM diagnostics using a 75 g oral glucose tolerance test. Maternal glucose was assessed from venous plasma at fasting, 1 h and 2 h. Venous blood were collected in Fluoride Citrate tubes and frozen. Samples were analyzed at five central laboratories using four different automated glucose Hexokinase methods and GDM prevalence was evaluated according to WHO2013 diagnostic criteria.RESULTS: Maximum inter-laboratory bias was 0.19, 0.30 and 0.27 mmol/L in fasting, 1 h and 2 h samples, respectively. GDM prevalence ranged 30.0-41.1% across laboratories.CONCLUSION: Inter-laboratory bias for mean venous glucose was low and within desirable limits. Nonetheless, the impact on GDM prevalence was considerable, which may inappropriately affect clinical practice.

AB - BACKGROUND AND AIMS: The diagnosis of gestational diabetes mellitus (GDM) is based exclusively on glucose measurements, which are highly influenced by pre-analytical and analytical factors. Therefore, poor agreement across laboratories may affect the prevalence of GDM. We aimed to determine the inter-laboratory bias of glucose measurements and the impact on GDM prevalence.MATERIAL AND METHODS: A prospective cohort study of women (n=110) referred for second-trimester GDM diagnostics using a 75 g oral glucose tolerance test. Maternal glucose was assessed from venous plasma at fasting, 1 h and 2 h. Venous blood were collected in Fluoride Citrate tubes and frozen. Samples were analyzed at five central laboratories using four different automated glucose Hexokinase methods and GDM prevalence was evaluated according to WHO2013 diagnostic criteria.RESULTS: Maximum inter-laboratory bias was 0.19, 0.30 and 0.27 mmol/L in fasting, 1 h and 2 h samples, respectively. GDM prevalence ranged 30.0-41.1% across laboratories.CONCLUSION: Inter-laboratory bias for mean venous glucose was low and within desirable limits. Nonetheless, the impact on GDM prevalence was considerable, which may inappropriately affect clinical practice.

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U2 - 10.1016/j.cca.2023.117414

DO - 10.1016/j.cca.2023.117414

M3 - Journal article

C2 - 37263535

SN - 0009-8981

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JO - Clinica chimica acta; international journal of clinical chemistry

JF - Clinica chimica acta; international journal of clinical chemistry

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The impact of inter-laboratory glucose bias on the diagnosis of gestational diabetes mellitus: Comparison of common automated central laboratory methods

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